NCT04149899

Safety and IOP-Lowering Effects of WB007

A Phase 1/2a Assessment of WB007 Ophthalmic Solution in Subjects With Primary Open-Angle Glaucoma or Ocular Hypertension

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 77 (actual)
• Sponsor: Bausch & Lomb Incorporated · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study evaluated the safety and IOP-lowering effects of WB007 in adults with primary open-angle glaucoma or ocular hypertension in both eyes. This was a 2-part study. Part 1 was a 3-period dose escalation that evaluated 3 concentrations of WB007 ophthalmic solution following a single dose in one eye. Part 2 was a randomized, double-masked, parallel comparison that evaluated two concentrations of WB007 (selected based on Part 1 results) in both eyes compared with timolol 0.5% for 14 days.

Conditions

• Glaucoma, Primary Open Angle
• Ocular Hypertension

Interventions

Type	Name	Description
DRUG	WB007 0.05%	WB007 Ophthalmic Solution 0.05%
DRUG	WB007 0.15%	WB007 Ophthalmic Solution 0.15%
DRUG	WB007 0.4%	WB007 Ophthalmic Solution 0.4%
DRUG	Timolol 0.5%	Timolol Maleate 0.5% Ophthalmic Solution

Timeline

• Start date: 2019-11-14
• Primary completion: 2021-01-31
• Completion: 2022-12-14
• First posted: 2019-11-04
• Last updated: 2025-03-27
• Results posted: 2023-03-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study